Kornimate/medical-research-clean huggingface dataset:
a clinical trial on the antipsychotic properties of cannabidiol

Conditions: Schizophrenia; Psychotic Disorders

Summary: the purpose of this study is to determine whether cannabidiol, a herbal cannabinoid, is effective in the treatment of acute schizophrenic or schizophreniform psychosis in a placebo-controlled, randomized double-blind study.

despite recent advances in the treatment of schizophrenia and schizophreniform disorders, there is still a need to develop efficient and better tolerated psychopharmacological approaches to this group of diseases. the endogenous cannabinoid system provides a promising target in the pharmacotherapy of these disorders. this approach is based upon recent findings indicating that the human endogenous cannabinoid system is significantly involved in the pathogenesis of schizophrenia and that cannabidiol is effective in treating acute psychotic symptoms of schizophrenic patients. we will investigate cannabidiol versus placebo in a randomized, double blind design with extensive safety measures. the primary hypothesis to be tested is that cannabidiol is expected to be superior to placebo in the treatment of acute schizophrenic and schizophreniform psychoses with regard to its antipsychotic efficacy.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of schizophrenic or schizophreniform psychosis * minimal initial score of 36 in the bprs total score and a minimum of 12 in the bprs psychosis cluster, including items 4 (conceptional disorganisation), 8 (exaggerated self-esteem), 12 (hallucinatory behaviour), and 15 (unusual thought content) * exclusion of pregnancy in female subjects through negative β-hcg test exclusion criteria: * lack of accountability * pregnancy or risk of pregnancy or lactation. * other relevant interferences of axis 1 according to diagnostic evaluation through mini including undifferentiated residual forms of schizophrenia. * treatment with depot-antipsychotics during the last three months. * severe internal or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures. positive hepatitis-serology. * qtc-elongation. * acute suicidal tendency of or hazard to others by the patient

Keywords: schizophrenia and disorders with psychotic features
br55 in prostate cancer: an exploratory clinical trial

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine whether br55 is able to identify areas of vegfr2 expression in human prostate by ultrasound molecular imaging. this will be compared with histopathology analysis (location based on expression of vegfr2 in tissue specimens determined by immuno-histochemistry, ihc).


Eligibility criteria:
inclusion criteria: * male patient, age ≥ 40 years old * has a histology proven focal prostate cancer lesion * the patient is already scheduled for prostatectomy not earlier than 3 days and at the latest 15 days after br55 administration * provides written informed consent and is willing to comply with protocol requirement exclusion criteria: * has a body weight greater than 95 kg (this weight limitation is required in order to maintain the active component of the drug under 100μg) according to the indication of the emea guideline m3 for this type of study * has documented acute prostatitis or urinary tract infections * is known to suffer from stable angina pectoris and/or proven coronary disease, or to have symptoms suspicious of coronary disease * with history of any clinically unstable cardiac condition including class iii/iv cardiac failure or right-to-left shunts * has had severe cardiac rhythm disorders within the last 7 days * has severe pulmonary hypertension (pulmonary artery pressure \>90 mmhg) or uncontrolled systemic hypertension or respiratory distress syndrome * has received a prostate biopsy procedure within 30 days before admission into this study * has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study. * is determined by the investigator that the patient is clinically unsuitable for the study. * is incapable of understanding the language in which the information for the patient is given * participation in a concurrent clinical trial or in another trial with an investigational compound within the past 30 days;

Keywords: prostate cancer ultrasound molecular imaging contrast agent br55 vegfr2
antimicrobial de-escalation strategy in medical patients

Conditions: Infections

Summary: the purpose of this pilot study is to assess the impact of an antibiotic de-escalation strategy on the clinical outcomes (clinical cure or improvement) of medical patients related to the usage of of broad-spectrum antimicrobial agents.

this is an open-label, case-control, pilot study involving medical patients with serious infections who are prescribed meropenem or piperacillin/tazobactam, at surrey memorial hospital. patients in the experimental arm (cases) will be required to provide an informed consent. a team consisting of an infectious diseases specialist, medical microbiologist and clinical pharmacists will prospectively assess antimicrobial therapy in the enrolled subjects in the prospective arm and make recommendations for antimicrobial de-escalation. the control group will consist of subjects drawn from historic data of patients on the same medical unit(s) who will be matched based on age, sex, use of broadspectrum antibiotics (meropenem or piperacillin/tazobactam) and infectious diseases diagnosis.

Eligibility criteria:
inclusion criteria: * age 19 years and over * suspected or confirmed infection for which a meropenem and/or piperacillin/tazobactam is prescribed. this will include any patient who is other concomitant antibiotic(s) such as vancomycin * subject admitted to smh medical unit(s) * pregnant patient (or patients wishing to become pregnant) exclusion criteria: * age less than 19 years * granulocytopenia (\< 1x109/l) * allergy or intolerance to meropenem or piperacillin-tazobactam. * febrile neutropenia * cystic fibrosis

Keywords: antimicrobial de escalation meropenem piperacillin tazobactam medical patients appropriate use cost savings antimicrobial de-escalation strategy
study to test a computer-assisted support system to improve patient-centered care and symptom relief in cancer patients

Conditions: Cancer; Lymphoma; Leukemia; Stem Cell Transplantation

Summary: patient-provider shared decision making and the inclusion of patients' illness experiences and preferences in patient care are prioritized areas in health care. choice is a computer-based support system for patient-centered symptom management of cancer patients developed for this purpose. in this randomized clinical trial at rikshospitalet- radiumhospitalet hf 145 adult stem-cell transplantation and newly diagnosed lymphoma and leukemia patients used choice for assessments of their symptoms, problems and priorities for care at in-and outpatient visits during treatment and rehabilitation. in the experimental group this information was shared with physicians an nurses for subsequent care planning, but not in the control group. this study tested effects of choice on symptom- related patient care and outcomes of symptom relief, patients' needs for care over time and patient satisfaction;(2) analyzed how patients' symptoms, needs for care varied during illness/treatment stages; and (3) evaluated choice' ease of use and user satisfaction. controlling for gender, age, diagnosis, and type/stage of treatment, education, depression, health related quality of life, and social support, repeated measurement models were used to test differences and variations in outcome variables within and between groups and over time.

as above

Eligibility criteria:
inclusion criteria: * starting treatment for a newly diagnosed acute myelogenous leukemia (aml), lymphatic leukemia (all), hodgkin or non-hodgkin lymphoma, or * starting treatment for a recurrence of the disease; * starting treatment with allogenous or autologous stem cell transplantation (sct). * above 18 years of age. exclusion criteria: * having received radiation on the brain

Keywords: symptom management cancer patient-centered care
can sensorimotor function predict graft rupture after acl reconstruction

Conditions: Anterior Cruciate Ligament Injuries

Summary: in this longitudinal prospective cohort study including young people with anterior cruciate ligament (acl) reconstruction, the investigators will evaluate if poor sensorimotor function at baseline can predict 1) graft rupture 2) the risk of contra-lateral acl injury and 3) failure to return to sport/previous activity level within 3 years following acl reconstruction.

in this longitudinal prospective cohort study including young athletic men and women (aged 15-35) with acl reconstruction (aclr), it will be investigated if poor sensorimotor function at baseline (1 year post aclr), such as hop performance, muscle strength and postural orientation can predict 1) graft rupture 2) the risk of contra-lateral acl injury and 3) failure to return to sport/previous activity level within 3 years following aclr. statistics separate logistic regression models will be used to elucidate the influence of each muscle sensorimotor function variable on the outcomes (graft rupture, contra-lateral injury, return to sport/activity level failure), adjusted for potential confounders. with the lsi for the single-leg hop test as main outcome, power calculations show that with a re-injury rate of 7%, an estimated odds ratio of 0.95, power=80% and alpha=5 %, at least 174 individuals are needed. based on this calculation, 200 individuals will be included for the prospective analysis, allowing for an approximate drop-out of 10%.

Eligibility criteria:
inclusion criteria: * 8-16 months after acl reconstruction * with or without associated injuries to other structures of the knee (e.g., collateral ligament(s), meniscal injury) * age 15-35 years. exclusion criteria: * acl injury other knee and previous acl injury index knee * diseases or disorders overriding the knee condition (e.g., neurological or rheumatological disease) * not understanding the languages of interest (any scandinavian language or english).

Keywords: anterior cruciate ligament injury re-injury muscle function functional performance rehabilitation physiotherapy sensorimotor control
a study to continue asp015k treatment to rheumatoid arthritis patients who completed phase iib study or phase iii study of asp015k

Conditions: Arthritis, Rheumatoid

Summary: this study evaluated the safety and efficacy of long-term administration of asp015k in patients who have completed phase iib or phase iii studies.

this study was an extension study conducted as an open-label multicenter study in rheumatoid arthritis (ra) participants who completed the phase iib study of asp015k \[015k-cl-raj1 (hereinafter referred to as study raj1)\], phase iii study of asp015k \[015k-cl-raj3 (raj3)\], or phase iii study of asp015k \[015k-cl-raj4 (raj4)\]. after the marketing approval in japan on 26 mar 2019, this study continued as "post marketing clinical study" in japan. in taiwan and korea, this study continued as "clinical study". participants received oral asp015k once daily (qd) after breakfast. the asp015k dose was increased later for participants who have no safety problems but showed lack of efficacy. the duration of treatment with the study drug was differed depending upon the participants.

Eligibility criteria:
inclusion criteria: * subject has completed treatment with the study drug in studies raj1, raj3 or raj4 as specified in the protocol * the subject himself/herself wishes to continue taking the study drug, and the investigator or sub-investigator deems continued administration to be necessary or appropriate exclusion criteria: * there were abnormal findings in the x-ray taken at week 0, and an acute or chronic infection, tuberculosis infection, or malignancy is suspected * hepatitis b virus or hepatitis c virus carrier or has a history of a positive test for human immunodeficiency virus (hiv) infection * subject has concurrent autoimmune disease (except sjogren's syndrome) other than ra or a history of it * subject has a clinically significant infection or disease (requiring hospitalization or parenteral therapy) * subject has qtc \< 300 msec on ecg measurements performed at the study site at week 52 of studies raj3 or raj4 and has qtc \< 300 msec at retest.

Keywords: smyraf rheumatoid arthritis peficitinib asp015k
the aim is to identify recurrent genomic mutations and/or predisposing polymorphisms in patients with sporadic cases of multiple myeloma

Conditions: Multiple Myeloma

Summary: there is a growing body of data suggesting that the the risk of developing multiple myeloma, or myelomagenesis, is associated with genetic alterations occurring in the tumor cells. a limited number of candidate genes and polymorphisms have been reported in patients with this disease. in this study the investigators will compare the genetic information obtained on purified abnormal plasmocytes obtained from patients with multiple myeloma with available public databases in an effort to identify and if possible validate the role of certain mutations and/or polymorphisms in myelomagenesis. plasmocytes will be obtained by immunomagnetic enrichment using cd138+ beads.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma * availability of abnormal plasmocytes exclusion criteria: - none

Keywords: genetic predisposition mutations sporadic multiple myeloma
functional and structural changes in the central nervous system following spinal cord injury

Conditions: Spinal Cord Injuries; Neurogenic Bladder Dysfunction; Degenerative Cervical Spinal Stenosis

Summary: building on recent improvements, state-of-the-art functional mri will be applied as an advanced diagnostic tool for the lumbosacral cord in spinal cord injury (sci) patients to characterize the remaining neuronal activity of the motor and sensory neurons. alterations in the activity pattern will reveal the effect upon task-related spinal cord activity of the lower motor neurons and sensory neurons undergoing trauma-induced neurodegeneration, at a spatial specificity that has not been possible so far. results of this study will be of crucial importance because sci patients can only profit from regeneration-inducing therapies if spinal neuronal function is preserved below the level of lesion.


Eligibility criteria:
inclusion criteria: * age \> 18 years * informed consent * willing to take part and follow requirements of the protocol patients additionally need to fulfil the following study-specific inclusion criteria: cross-sectional study: * chronic traumatic sci (\> 12 months after injury) or * diagnosed degenerative spondylotic myelopathy (dcm) longitudinal study: * acute traumatic sci (\< 2 months after injury) or * patients with neurogenic lower urinary tract dysfunction (nlutd) who undergo routine tibial nerve stimulation (tns) treatment as part of their rehabilitation (but independently of this study) at balgrist university hospital exclusion criteria: * age \< 18 years * contraindications for mri (presence of pacemaker or other type of stimulator in the body, presence of metallic foreign body in or on the body, etc.); we will comply with the imaging center's (scmi) guidelines and in case of doubt we will exclude the participant from the study * no informed consent * history of psychiatric or neurological disease, apart from those induced by sci (e.g.epilepsy) * history of skull opening or head trauma * known or suspected non-adherence, drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. * women who are pregnant (when uncertain, participants will undergo urine testing) or breastfeeding * intention to become pregnant during the course of the study * body mass index (bmi) \> 35 * individuals especially in need of protection (according to research with human subjects published by the swiss academy of medical sciences)
health of children born from icsi with aoa (aoa-babies)

Conditions: Infertility; Intracytoplasmic Sperm Injection

Summary: the investigators follow up on the development of children born from icsi-aoa using the developmental red flags and ages \& stages third edition (asq-3) questionnaires to give strong evidence about the safety of aoa in assisted reproductive technology.

intracytoplasmic sperm injection (icsi) is the most widely utilized assisted reproductive technique (art) worldwide. fertilization rates obtained after icsi treatment are reported between 70 and 80%, representing the most efficient art; however, complete post-icsi fertilization failure still occurs in 3-5% of cases. the leading cause of failed fertilization is failure to achieve oocyte activation, a crucial stage in the initiation of embryo development during fertilization. assisted oocyte activation (aoa) using a calcium ionophore has been used for over a decade following icsi fertilization failure. aoa is not considered a routine practice of art yet, which is only suitable for patients with proper indications, including (i) total fertilization failure or low fertilization rate (\<30%) in the previous ivf; (ii) severe male factor infertility; (iii) patients with a history of embryo arrest or poor embryo quality in previous ivf cycle. regarding technique, the artificial rise of induced calcium rises cannot precisely mimic the physiologically sperm-induced calcium oscillations. little is known yet about the possible adverse effects of ionophores on post-implantation embryo development. numerous studies have been conducted to compare the development of children born from icsi - aoa versus non-aoa. thus, the investigators performed this study to investigate the physical, mental, and motor development of children born following icsi - aoa using the developmental red flags and ages \& stages third edition (asq-3) questionnaires.

Eligibility criteria:
inclusion criteria: all single, live babies born following icsi with aoa and icsi without aoa from 08/2020 to 04/2021. parents consent to participate in the study. group icsi+aoa: embryos from icsi with aoa with calcium ionophore in the icsi+aoa group, indications of aoa are: * previous failed ivf treatment with no fertilization or poor fertilization rate (fertilized oocytes/pick-up oocytes\<35%) or poor embryo result (number of embryos/pick-up oocytes\<35%, \<3 embryos, no good-quality embryo) * using sperm after retrieval technique, cryptozoospermia group control: embryos from icsi without aoa. in the control group, the indications of aoa for the next ivf cycle (if patients continue the next ivf cycle) are: * currently failed ivf treatment with no fertilization or poor fertilization rate (fertilized oocytes/pick-up oocytes\<35%) or poor embryo result (number of embryos/pick-up oocytes\<35%, \<3 embryos, no good-quality embryo) exclusion criteria: embryos with pgt. oocyte donation

Keywords: icsi total fertilization failure aoa asq-3 health of children
nmes to improve eyelid functions in cranial nerve (cn) iii and vii palsy

Conditions: Blepharoptosis; Lagophthalmos

Summary: traumatic brain injury, stroke and other neurological conditions may result in weakness of the muscles that either open or close the eye. this is generally a result of impaired functioning of the oculomotor or facial cranial nerves. current treatments to improve eye opening or closing are either invasive or largely ineffective. this study tests a noninvasive means of improving eyelid opening and closing by applying a previously demonstrated safe and effective neuromuscular electrical stimulation (nmes) intervention to the muscles controlling eyelid movement. participants in this study will either receive the investigational nmes protocol 30 min per day for five days or a sham nmes for the same period. the primary outcome for this study is the participants' ability to open or close their affected eye. secondary outcomes include additional measures of eye and corneal health.


Eligibility criteria:
inclusion criteria: * cranial nerve iii (oculomotor nerve) and/or cranial nerve iv (facial nerve) palsy. * able to read and communicate in english. exclusion criteria: * idiopathic onset of cn iii and/or cn iv palsy. * traumatic injury to the eye or eyelid. * active wounds in the treatment area. * presence of swelling or infection in or surrounding the affected eye. * diminished sensation in the area to be treated.

Keywords: nmes
study evaluating neratinib plus paclitaxel vs trastuzumab plus paclitaxel in erbb-2 positive advanced breast cancer

Conditions: Breast Cancer

Summary: this study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbb-2-positive locally recurrent or metastatic breast cancer. the study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbb-2 (her2) positive breast cancer. the study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.


Eligibility criteria:
inclusion criteria: * erbb-2 positive locally recurrent or metastatic breast cancer * eastern cooperative oncology group (ecog) 0-2 * measurable disease * availability of tumor tissue for her2 status confirmation exclusion criteria: * prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease * prior erbb-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting * progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy * history of heart disease * history of gastrointestinal disease

Keywords: erbb-2 positive advanced breast cancer hki-272 neratinib nerlynx her2 pb-272 metastatic breast cancer
increasing the variety of vegetables and fruits served to preschool children at a snack

Conditions: Obesity; Feeding Behaviors

Summary: intake of vegetables and fruits in preschool children is less than recommended amounts. although offering a variety of foods has been shown to increase intake, this effect has not been well studied for low-energy-dense foods. the purpose of this study was to test whether increasing the variety of vegetables and fruits served to preschool children affected the amount eaten. the hypotheses were that increasing the variety of vegetables and fruits would increase both the amount selected and the amount eaten.


Eligibility criteria:
inclusion criteria: * attenders at the relevant child care center exclusion criteria: * allergy or sensitivity to any test food

Keywords: dietary variety vegetable intake fruit intake